Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis (CHAMPION)

July 15, 2008 updated by: Abbott

A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

271

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Abbott Park, Illinois, United States, 60064
        • Global Medical Information-Abbott

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history who has had a diagnosis of psoriasis for at least 12 months and stable moderate to severe chronic plaque psoriasis
  • Subject is a candidate for systemic therapy or phototherapy and has active psoriasis despite treatment with topical agents.
  • Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections.
  • Male subjects must hve been vasectomized or practicing birth control.

Exclusion Criteria:

  • Previous systemic anti-TNF therapy.
  • Prior use of MTX.
  • Known hypersensitivity to the constituents of adalimumab.
  • Systemic therapy for psoriasis for at least 4 weeks prior to Baseline; except for biologic therapies, which must be discontinued at least 12 weeks prior to enrollment.
  • Topical psoriasis therapy for at least 2 weeks prior to Baseline, except for non-corticosteroid shampoos, bland (no alpha or beta hydroxy) emollients and low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only.
  • Use of tanning beds, excessive sun exposure, or phototherapy (UVB, UVA), for at least 2 weeks prior to Baseline.
  • Use of PUVA for at least 4 weeks prior to Baseline.
  • Use of oral or injectable corticosteroids during the study.
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study.
  • Female subject who is pregnant or breast feeding or considering becoming pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
40 mg every other week following an 80 mg dose
Other Names:
  • ABT-D2E7
  • Humira
Active Comparator: B
MTX 7.5 to 25 mg once weekly
Placebo Comparator: C
placebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX)
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score.
Time Frame: Week 16
Week 16
Safety parameters
Time Frame: Every Study Visit
Every Study Visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Physician Global Assessment
Time Frame: Baseline - Week 16
Baseline - Week 16
PASI 50/90/100
Time Frame: Baseline - Week 16
Baseline - Week 16
DLQI
Time Frame: Baseline - Week 16
Baseline - Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Global Medical Information, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

July 17, 2008

Last Update Submitted That Met QC Criteria

July 15, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psoriasis

Clinical Trials on adalimumab

3
Subscribe